這是一項第三期、隨機、開放標籤、多中心、全球性研究，評估於完全手術切除（R0）後，對ctDNA陽性（由申辦方指定的ctDNA檢測確定）或具有至少一項高風險病理特徵之第一期腺癌NSCLC參與者，輔助Dato-DXd聯合rilvegostomig對比標準治療（SoC）的療效與安全性。
適應症：Non-small Cell Lung Cancer
收案條件
納入條件
- Histologically documented treatment-naive Stage I (T \< 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
- Complete surgical resection (R0) of the primary NSCLC
- Unequivocal no evidence of disease at post-surgical
- Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)
- ECOG of 0 or 1, life expectancy of \> 6 months and complete recovery after surgery
- Adequate bone marrow reserve and organ function
排除條件
- Sensitizing EGFR mutation and/or ALK alteration
- History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Significant pulmonary function compromise
- History of another primary malignancy within 3 years (with exceptions)
- Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled
- History of active primary immunodeficiency
- Clinically significant corneal disease
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。